Products Liability For Pharmaceutical Scientists

Edward P. RichardsHarvey A. Peltier Professor of LawLouisiana State University School

of Lawrichards@lsu.edu

http://biotech.law.lsu.eduClick Here For Updated Slides

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History of Drug Liability

FDA History is the History of Drug Injuries

FDA Regulation Tries to Prevent Future Injuries

Tort Litigation Compensates for Past Injuries

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Multiple Sovereigns

Tort Law for Drugs is State Law Basic Theories are the Same Significant Variation on Details Federal Courts Apply State Law

Individual Judges Have Great Discretion Many Case Depend on Whether the

Judge Admits the Plaintiff's Evidence Forum Shopping

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Negligence Traditional Cases Were Usually

Based in Negligence Had to Show Legal Relationship –

Privity No Relationship Between Patient and

Drug Company Ended with Pharmacist

Made Sense when Pharmacists Compounded all the Drugs

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Fall of Privity

Courts Found Privity Out of Date with the Industrial Revolution

Thomas v. Winchester (1852) Supplier Provided Belladonna rather

than Dandelion Privity would have Blocked the Claim Court Limited Privity for Dangerous

Activities

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Early Strict Liability Many States Imposed Strict Liability for

Ultrahazardous Activities Blasting Impounding Water

Plaintiff did not need to Show Negligence, only Injury Due to the Activity

Very Limited Application – not generally extended to Drugs

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Limits of Negligence

Must Show Breach of Standard of Care What a Reasonable Manufacturer

Would Do? Only Evidence is Other Manufacturers

Must Show What Happened to the Specific Batch

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Warranty Theories

Predate Strict Liability Related to UCC Warranties Cannot Disclaim for Personal

Injuries Based on Promises Special Problem for Promoting Off-

Label Uses

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Express Warranty Manufacturer Is Held to Specific

Promises Shatterproof Windshield Case

Claimed It Was Just “Puffing” Court Said It Was a Clear Promise Did Not Matter If It Was Impossible

Can Be Written or Verbal Can Physicians Give Binding Warranties

About Products?

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Implied Warranties Implied From the Context of the Sale

A Product Is Safe for What It Is Sold for FDA Approved Drugs Have Only the

Stated Risks Implied Warranty of Fitness for a

Specific Purpose Manufacturer or Seller Says the

Product Is Good for Something Other Than Its Usual Purpose

Use of Drugs For Unapproved Purposes

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Jeep Case

Jeep Sold for off the Road Use Rolled and Killed and Injured

Passengers Made Like a Sardine Can Manufacturer Claimed Improper Use

How Do You Prove? Advertising Representations by Sales Persons

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Shift to Strict Liability

Hard to Prove Negligence for Products Generic Goods - No Specific Information Defendant’s Have Lots of Resources

Defects Affect Lots of People Strict Liability Encourages Safety

Cannot Escape Liability by Just Doing What Others Do

Safer Products = Lower Costs

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Restatement of Torts 402a (1) One who sells any product in a defective

condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business

of selling such a product, and (b) it is expected to and does reach the

user or consumer without substantial change in the condition in which it is sold.

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Limited Defenses under 402a

(2) The rule stated in Subsection (1) applies although (a) the seller has exercised all

possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

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Unavoidably Unsafe Products Comment K Key Defense for Drugs

Recognizes that Many Drugs are Very Dangerous

Pasteur Rabies Vaccine Example Looks at the Label Information

Does it Explain How to Use the Drug? Does it Warn about Dangers? Did it Get to the Decision-maker?

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Who Else is Liable?

Usually Both Sellers and Manufacturers Are Liable

Health Care is Different Product v. Service Distinction The Patient is Not the Buyer The Doctor is Not the Seller The Hospital is Not (Considered) a

Supplier Limited Liability for Pharmacies

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Product Must Be Defective Manufacturing Defect

Easy to Prove Limited Number Affected Example: Improper Sterilization

Design Defect Effects Every Unit Includes Warnings Thalidomide, DES, Mer-29

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Plaintiff Must Show Causation Why Does the Defect Make the

Product Unreasonable Dangerous? Did the Defect Cause the Patient's

Injury? Often Circular in Drugs Bendectin Causes Birth Defects so

Bendectin is Defective so Bendectin Caused My Baby's Birth Defect

Expert Testimony is Critical

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Is it Unreasonably Dangerous?

Courts Use Two Tests Consumer Expectations

Usually OTC Drugs Big Issue with Direct Promotion

Risk/Benefit Analysis Rx Drugs Little Deference to FDA Determinations Danger to One Group Can Deny to All

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What if the Doc Uses the Drug Improperly?

Learned Intermediary Defense Was the Doc Properly Warned? Did She Rely on Manufacturer's

Representations? Does the Manufacturer/Seller

Encourage Misuse? Over-Promotion - Chloramphenicol Selling For Improper Use - Oximeters

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FDA Labels And Products Liability

Is There A Regulatory Compliance Defense?

What If The FDA Will Not Let You Include A Warning?

What Is The Evidentiary Value Of An FDA Label?

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Brave New World Internet Sales

No Doc No Information Manufacturers Know About It

Non-Physician Prescribers States Are Broadening Who Can Prescribe Courts Have Not Found Nurses, Physicians

Assistants, and other Non-Physicians to be Learned Intermedi22aries